mtm’s p16 and Ki-67 dual staining test identifies high-grade cervical disease in women with ASC-US and LSIL

mtm laboratories, a privately held diagnostics company developing, manufacturing and globally commercializing in vitro diagnostics for cervical cancer early detection and diagnosis, today announced the publication of a new paper showing that dual staining for p16 and Ki-67 can pinpoint the underlying high-grade cervical disease with a high degree of sensitivity and specificity in women with ASC-US or LSIL cytology results. These are a group of patients currently poorly served by existing screening technologies, with too many referred for unnecessary colposcopy. The paper, which details the EEMAPS study results, has been published electronically in Cancer Cytopathology on March 25, 2011 ahead of print.

“Because the test can pinpoint which women are most likely to have cervical disease and need follow up, this should reduce a large number of the unnecessary, uncomfortable and costly colposcopies carried out on women with ASC-US or LSIL.”

The EEMAPS study used the advanced biomarker combination CINtec^® PLUS, which was launched by mtm in early 2010 in Europe. Residual materials from a previous pan-European retrospective cytology study were used to prepare additional slides for p16 and Ki-67 dual immuno-staining. In total, 361 ASC-US and 415 LSIL cases with corresponding biopsy results and HPV test results were available for dual stain cytology analysis. The presence of one or more dual-stained cervical epithelial cell(s) defined a positive test result with CINtec^® PLUS, independent from morphology interpretation. The clinical results showed that the sensitivity of the dual stain for high-grade disease was 92.2% (71/77) for ASC-US, and 94.2% (129/137) for LSIL cases, which is equivalent to the sensitivity results obtained for HPV testing. However, specificity was significantly higher for CINtec^® PLUS as compared to HPV testing; 80.6% vs. 36.3% for ASC-US and 68.0% vs. 19.1% for LSIL.

"mtm's CINtec^® PLUS is the first test that provides high sensitivity and high specificity for underlying high-grade cervical disease in a single product, irrespective of women's age and the individual HR-HPV genotype," commented Bob Silverman, CEO of mtm laboratories. "Because the test can pinpoint which women are most likely to have cervical disease and need follow up, this should reduce a large number of the unnecessary, uncomfortable and costly colposcopies carried out on women with ASC-US or LSIL."

ASC-US and LSIL are definitions for equivocal and mild to moderate abnormal cytology findings on Pap tests, and may represent 5-8% of all cervical cytology cases. While most of these findings are negative for high-grade disease, 15-20% of LSIL and 6-10% of ASC-US will harbour high-grade disease. Together, these two categories of cytology represent the source for about 60% of all cases of high-grade cervical disease in women. Unfortunately, these Pap cytology results are not adequate predictors in determining which ASC-US or LSIL cases require intervention due to the low rates of underlying disease. Adjunctive HPV testing also has limitations due to unsatisfactory specificity.

SOURCE mtm laboratories AG